MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 BARD SOFT MESH; SURGICAL MESH

Catalog Number	0117011
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Adhesion(s) (1695); Scar Tissue (2060); Hernia (2240)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Root cause is inconclusive, no conclusion can be made as to the extent to which the implant may have caused or contributed to the patient's postoperative course.Note, the manufacturing date (15-jan-2012) is considered to be a best estimate.This mdr represents the bard soft mesh (device 2).An additional supplemental emdr was submitted to represent the bard flat mesh (device 1).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
Per information provided: (b)(6) 2010 - patient was diagnosed with umbilical/epigastric hernia thereby underwent open repair with implant of bard flat mesh (device 1).Per operative notes, ¿a vertical incision was made just to the right of the umbilicus.The hernia sac was just above the umbilicus which was dissected out.A bard flat mesh (device 1) was placed into the defect and closed with sutures.¿ (b)(6) 2012 - patient was diagnosed with recurrent epigastric hernia, adhesion thereby underwent open repair with explant of bard flat mesh (device 1) and implant of bard soft mesh (device 2).Per operative notes, ¿a vertical incision was made.The hernia sac was dissected out.Lysis of adhesion was performed.Previously placed bard flat mesh (device 1) was removed partially.A bard soft mesh (device 2) was placed and secure it with sutures.¿ (b)(6) 2019 - patient was diagnosed with recurrent ventral incisional hernia, adhesion, scar tissue, thereby underwent open repair with implant of synthetic mesh.Per operative notes, ¿a vertical midline incision was made to the old scar.Hernia sac was dissected out.Old scar tissues and adhesions were taken down.Previously placed meshes were well incorporated.A synthetic mesh was placed into the defect and closed with sutures.¿.

• Brand Name: BARD SOFT MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 100 crossings blvd.; warwick RI 02886
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 23786675
• Report Number: 1213643-2025-01185
• Device Sequence Number: 17571002
• Product Code: FTL
• UDI-Device Identifier: 00801741030888
• UDI-Public: (01)00801741030888(17)170228(10)HUWA1731
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K052155
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: 0117011
• Device Lot Number: HUWA1731
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 12/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2012
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Male